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Chronic PainNCT02969434

Chronic Pain and Assessment of Sleep

A study testing Sleep assessment tools in people with Chronic Pain, run by University of Aberdeen at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy, improve both sleep quality and also pain management, and reduce interference of pain with daily activities. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Sleep assessment tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2016to 20 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged 16 or over Chronic pain Fluent in English Able to report on their health and pain status (neurologically stable)

Who cannot join

  • Under 16 years

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Aberdeen/NHS Grampian

    Aberdeen, Scotland, AB25 2ZB

Other trials in United Kingdom

About this study

Official title: Accuracy of the Brief Pain Inventory in Identifying Sleep Disturbances in Chronic Pain Patients

Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy, improve both sleep quality and also pain management, and reduce interference of pain with daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep has been proposed as marker of effective pain management. Hence it is useful to evaluate sleep disturbances in chronic pain population both in clinical and research setting. There are many tools to evaluate sleep quality; the routinely used simple brief pain inventory (BPI) has a single question about sleep. We will compare three dedicated sleep measures to the BPI in patients with chronic pain.

Read the detailed description

The prevalence of sleep disturbances including insomnia is high in chronic pain patients and is known to contribute to the maintenance of chronic pain. A large survey estimated that chronic pain of moderate to severe intensity occurs in 19% of adult Europeans, and that 50% of this cohort reported feeling tired all the time. Studies using specific sleep assessment tools have found that up to 50% of patients complain of poor sleep and 40% have clinically defined insomnia.

Though association between sleep and pain is well established, it is still unclear about the direction of causality. A recent narrative review has found that sleep impairments reliably predict worsening of chronic pain and correlate with higher visual analogue pain scores. Therapies targeted at improving sleep hygiene, including cognitive behavioral therapy, have been shown to not only improve sleep quality, but also pain management and reduce the degree to which pain interfered with daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep has been proposed as marker of effective pain management.8 Hence it is useful to evaluate sleep disturbances in chronic pain population both in clinical and research setting.

There are at least 30 different sleep evaluation scales and questionnaires. Previous works have used several different tools to quantify the prevalence and severity of sleep disturbance in chronic pain patients. The most commonly used tools are the Pittsburgh Sleep Quality Index (PSQI) and the Medical Outcomes Study (MOS) Sleep Scale. The PSQI has an extensive body of evidence in detecting primary insomnia, demonstrating a high test-retest reliability and contains domains which are of importance when measuring sleep disturbance in chronic pain. However, none of the aforementioned tools directly assesses the impact of pain on sleep, and are as such not capable of establishing a direct link between sleep disturbance and chronic pain. Chronic Pain Sleep Inventory (CPSI) and Pain and Sleep Questionnaires (PSQ) were developed to assess the impact of pain on pain related sleep disturbances. These multidimensional items were abbreviated to Sleep Pain Index (SPI) and Pain and Sleep three-item index (PSQ-3) and specifically targeted at assessing sleep disturbance in patients with chronic pain. Both SPI and PSQ- 3 have been tested for their reliability and validity. The Verran Snyder-Halpern (VSH) scale uses visual analogue scales to describe sleep quality, latency and disturbance but none of these questionnaires have been widely adopted either in research setting or clinical practice. Though the reasons are not known, people may find multi-items dedicated questionnaires as cumbersome and overwhelming. One way to circumvent the issue is to utilize a single item questionnaire or even use a single item on the widely used pain questionnaire. Single item numerical rating scales to measure sleep quality have shown modest correlation with the MOS sleep scale and may be of particular benefit when repeated measurements are used due to their simple nature.

Brief Pain Inventory (BPI) is one of the most widely used measurement tool and is advocated as one of the core outcomes tool for pain clinical trials. BPI provides an overall picture of pain status and its interference with general health and serves to help monitor response to treatment with time. Included in the BPI is a single numerically rated score assessing the degree to which pain interferes with sleep. This item has the potential to detect the impact of pain on pain related sleep disturbances thereby insomnia and therefore lead to treatment. Validation of this commonly used questionnaire BPI, against a formal sleep assessment tools would not only allow identification of patients with significant sleep disturbance and facilitate prompt targeted treatment but also help to evaluate the pain treatment.

Conditions
Chronic Pain
Being tested
Sleep assessment tools
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep assessment toolsOther

    Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).

Study groups in NCT02969434
Study groupRoleWhat they receive
Sleep questionnaires assessment toolsExperimentalInterventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).
Receives: Other: Sleep assessment tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment of 50 patients

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionApr 2017
  4. Study completion20 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969434
Sponsor's protocol ID
1/027/16
Status last verified
Jan 2017
First submitted
17 Nov 2016
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep assessment tools in people with Chronic Pain, run by University of Aberdeen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment of 50 patients (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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